Weyera Mental Health Pilot Intervention

NCT06960187 | Recruiting

• 2 other identifiers: STUDY00008231R21MD019304-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to pilot a group-level intervention focused on mental health and resilience among Ethiopian and Eritrean youth. The study follows previous work that showed high rates of mental health outcomes (depression, anxiety, post-traumatic stress disorder (PTSD)) among Ethiopian and Eritrean youth in Atlanta. The goal is to determine the acceptability, feasibility, and safety of this culturally relevant group-level intervention before a larger trial to improve resilience processes that support mental wellness in a community-based setting.

Conditions

Mental Health Issue

Keywords

Eritrean origin; Ethiopian; Psychoeducation; Coping skills

Outcome Measures

Primary Outcomes (6)

• Satisfaction Survey

  Acceptability will be measured using satisfaction surveys at the end of each session.

  2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Acceptability of the intervention is a subset of participants

  A subset of participants will complete qualitative interviews: Open-ended questions at the end of the study. There is no measuring scale for these interviews.

  6 months (endline).

• Recruitment Rates

  Feasibility will be measured by monitoring the recruitment rate (the number of screenings conducted, along with the proportion of eligible individuals who agree to enroll).

  2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Retention

  Retention of participants throughout the 8 sessions will be monitored using attendance logs during each visit. This will help determine feasibility of the program.

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Fidelity

  Fidelity will be measured using the intervention logs to assess the extent to which the intervention components (number of sessions completed, length of sessions, topics discussed) adhere to the intervention protocol.

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Adverse Events

  Adverse event tracking forms will be used to track any safety related issues with the intervention.

  Throughout study participation up to 6 month (endline)

Secondary Outcomes (7)

• Center for Epidemiologic Studies Depression (CES-D) Scale

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Generalized Anxiety Disorder 7-item scale

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5)

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).

• Perceived social support

  Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)

• Affirming ethnic identity beliefs

  6 months (endline).

Study Arms (2)

Intervention

OTHER

Participants enrolled in the intervention group will begin the intervention 1-2 weeks after group assignment and will complete a baseline survey before the start of the intervention, satisfaction surveys at the end of each session, and an endline survey. At the end of the intervention, a subset of participants will also take part in in-depth interviews

Behavioral: Weyera Intervention

Wait-List Control Group

OTHER

A wait-list control design ensures the ethical treatment of participants by guaranteeing that all individuals will have access to the potentially impactful intervention after a brief waiting period. Participants in the wait-list control group will begin the full intervention starting at month 4 following their enrollment.

Behavioral: Delayed intervention (waitlist control)

Interventions

Weyera Intervention BEHAVIORAL

Weyera intervention is an eight-week program featuring weekly, two-hour facilitated group sessions with 6-10 participants in each group, led by trained lay facilitators. Each session will address the weekly topic and introduce an evidence-based coping strategy (e.g., mindfulness, positive refocusing) that participants can practice over the following week. Within this outline, we will create intervention activities based on theory-based change methods and practical applications matched to objectives and determinants in the Logic Model of Change. Outline of major modules for the eight weeks: 1. Introduction to mental health 2. Stress and family pressure 3. Self-exploration and critical reflection 4. Intersectional Identities 5. Family Relationships 6. Discussing mental health in the Ethiopian and Eritrean communities 7. Trauma and Abuse 8. Navigating mental health services

Intervention

Delayed intervention (waitlist control) BEHAVIORAL

Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (pre-intervention), 6 months (immediate post-intervention), and 8 months (post-intervention).

Wait-List Control Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 29 years old
• Ethiopian and/or Eritrean ethnicity by self-report
• Able to read and understand English
• Resident of Atlanta Metropolitan Statistical Area
• Available and interested to participate in 2-hour weekly sessions over 8 weeks and complete relevant surveys

You may not qualify if:

• Age \< 18 or \> 29 years old
• Unwilling or unable to provide informed consent.
• Not a resident of the Atlanta Metropolitan Statistical Area

Sponsors & Collaborators

• Emory University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

RECRUITING

Ethiopian Community Association In Atlanta

Clarkston, Georgia, 30021, United States

RECRUITING

Eritrean-American Community Association of Georgia

Stone Mountain, Georgia, 30083, United States

RECRUITING

Study Officials

• Sophia Hussen, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Hussen, MD, MPH

CONTACT

(404) 616-2440; shussen@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health and Medicine

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 7, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The de-identified dataset will be available after the study and data analysis are complete.
• Access Criteria: All requests accompanied by a methodologically sound proposal must be emailed to the principal investigator.

Locations

US (3)